ES2266310T3 - Esterizacion de suspensiones de glucocorticosteriodes. - Google Patents
Esterizacion de suspensiones de glucocorticosteriodes. Download PDFInfo
- Publication number
- ES2266310T3 ES2266310T3 ES01997317T ES01997317T ES2266310T3 ES 2266310 T3 ES2266310 T3 ES 2266310T3 ES 01997317 T ES01997317 T ES 01997317T ES 01997317 T ES01997317 T ES 01997317T ES 2266310 T3 ES2266310 T3 ES 2266310T3
- Authority
- ES
- Spain
- Prior art keywords
- temperature
- composition
- formulation
- seconds
- suspension
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 239000000725 suspension Substances 0.000 title claims abstract description 37
- 239000000203 mixture Substances 0.000 claims abstract description 81
- 238000000034 method Methods 0.000 claims abstract description 64
- 238000009472 formulation Methods 0.000 claims abstract description 45
- 230000001954 sterilising effect Effects 0.000 claims abstract description 45
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 21
- 238000010438 heat treatment Methods 0.000 claims abstract description 16
- 239000003862 glucocorticoid Substances 0.000 claims abstract description 12
- 238000001816 cooling Methods 0.000 claims abstract description 6
- 230000000813 microbial effect Effects 0.000 claims abstract description 3
- 238000004659 sterilization and disinfection Methods 0.000 claims description 42
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims description 30
- 229960004436 budesonide Drugs 0.000 claims description 30
- 239000003814 drug Substances 0.000 claims description 15
- 229940079593 drug Drugs 0.000 claims description 14
- 239000004094 surface-active agent Substances 0.000 claims description 10
- 239000012141 concentrate Substances 0.000 claims description 8
- 238000003860 storage Methods 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- 238000007789 sealing Methods 0.000 claims description 3
- 239000002904 solvent Substances 0.000 claims description 3
- 238000007865 diluting Methods 0.000 claims description 2
- 239000011521 glass Substances 0.000 claims description 2
- 239000002184 metal Substances 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 238000007664 blowing Methods 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 239000002245 particle Substances 0.000 description 16
- 239000000047 product Substances 0.000 description 12
- 230000006378 damage Effects 0.000 description 10
- 238000012360 testing method Methods 0.000 description 10
- 238000012423 maintenance Methods 0.000 description 7
- 230000015556 catabolic process Effects 0.000 description 5
- 238000006731 degradation reaction Methods 0.000 description 5
- 238000001914 filtration Methods 0.000 description 5
- 230000036512 infertility Effects 0.000 description 5
- 230000002459 sustained effect Effects 0.000 description 5
- 230000034994 death Effects 0.000 description 4
- 231100000517 death Toxicity 0.000 description 4
- 239000008267 milk Substances 0.000 description 4
- 210000004080 milk Anatomy 0.000 description 4
- 235000013336 milk Nutrition 0.000 description 4
- 239000000825 pharmaceutical preparation Substances 0.000 description 4
- 229940127557 pharmaceutical product Drugs 0.000 description 4
- 229950008882 polysorbate Drugs 0.000 description 4
- 229920000136 polysorbate Polymers 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 238000005054 agglomeration Methods 0.000 description 2
- 230000002776 aggregation Effects 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 238000010924 continuous production Methods 0.000 description 2
- 230000006866 deterioration Effects 0.000 description 2
- 239000013583 drug formulation Substances 0.000 description 2
- 238000005429 filling process Methods 0.000 description 2
- 239000013020 final formulation Substances 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 239000006199 nebulizer Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 239000011148 porous material Substances 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 238000013094 purity test Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000002542 deteriorative effect Effects 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000002663 nebulization Methods 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000011272 standard treatment Methods 0.000 description 1
- 239000008223 sterile water Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J5/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Food Preservation Except Freezing, Refrigeration, And Drying (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0028763A GB0028763D0 (en) | 2000-11-24 | 2000-11-24 | Sterilisation of pharmaceuticals |
| GB0028763 | 2000-11-24 | ||
| GB0111745 | 2001-05-14 | ||
| GB0111745A GB0111745D0 (en) | 2000-11-24 | 2001-05-14 | Sterilization of pharmaceuticals |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2266310T3 true ES2266310T3 (es) | 2007-03-01 |
Family
ID=26245330
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES01997317T Expired - Lifetime ES2266310T3 (es) | 2000-11-24 | 2001-11-26 | Esterizacion de suspensiones de glucocorticosteriodes. |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US6863865B2 (fr) |
| EP (1) | EP1337279B1 (fr) |
| JP (1) | JP4048114B2 (fr) |
| AT (1) | ATE330638T1 (fr) |
| AU (1) | AU2002223896B9 (fr) |
| BR (1) | BR0115584A (fr) |
| CA (1) | CA2429574C (fr) |
| CY (1) | CY1105266T1 (fr) |
| CZ (1) | CZ301049B6 (fr) |
| DE (1) | DE60121023T2 (fr) |
| DK (1) | DK1337279T3 (fr) |
| ES (1) | ES2266310T3 (fr) |
| GB (1) | GB2374013C (fr) |
| HK (1) | HK1057492A1 (fr) |
| HU (1) | HUP0302630A3 (fr) |
| IL (1) | IL155935A0 (fr) |
| IS (1) | IS2528B (fr) |
| NO (1) | NO327380B1 (fr) |
| NZ (1) | NZ526118A (fr) |
| WO (1) | WO2002041925A1 (fr) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9704186D0 (sv) * | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
| CA2429574C (fr) * | 2000-11-24 | 2009-02-10 | Breath Limited | Sterilisation de produits pharmaceutiques |
| DE60325459D1 (de) | 2002-02-19 | 2009-02-05 | Resolution Chemicals Ltd | Auf lösungsmitteln basierende sterilisation von steroiden |
| RS57455B1 (sr) | 2002-07-02 | 2018-09-28 | Astrazeneca Ab | Sterilna vodena suspenzija koja sadrži ciklezonid |
| AU2003260754B2 (en) * | 2002-08-29 | 2009-12-03 | Cipla Limited | Pharmaceutical products and compositions comprising specific anticholinergic agents, beta-2 agonists and corticosteroids |
| SE524496C2 (sv) * | 2002-12-13 | 2004-08-17 | Tetra Laval Holdings & Finance | Styrning av steriliseringsanordning |
| EP1454636A1 (fr) * | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Stérilisation de médicaments glucocorticostéroides particulaires pour application pulmonaire |
| PE20050941A1 (es) * | 2003-12-16 | 2005-11-08 | Nycomed Gmbh | Suspensiones acuosas de ciclesonida para nebulizacion |
| US20070020298A1 (en) * | 2003-12-31 | 2007-01-25 | Pipkin James D | Inhalant formulation containing sulfoalkyl ether gamma-cyclodextrin and corticosteroid |
| US20070020299A1 (en) | 2003-12-31 | 2007-01-25 | Pipkin James D | Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid |
| EP1574222B1 (fr) | 2004-03-12 | 2011-02-09 | Cipla Ltd. | Procédé de stérilisation pour stéroïdes |
| WO2005088655A1 (fr) * | 2004-03-12 | 2005-09-22 | The Provost Fellows And Scholars Of The College Of The Holy And Undivided Trinity Of Queen Elizabeth Near Dublin | Milieu magnetoresistant |
| GB0410995D0 (en) | 2004-05-17 | 2004-06-23 | Norton Healthcare Ltd | Heat sterilization of glucocorticosteroids |
| ITSA20040012A1 (it) * | 2004-09-07 | 2004-12-07 | Genetec S P A | Processo di sterilizzazione di un glucocorticosteroide. |
| GB0425266D0 (en) * | 2004-11-16 | 2004-12-15 | Norton Healthcare Ltd | Pharmaceutical manufacturing process |
| EP1683514B1 (fr) * | 2005-01-20 | 2012-05-23 | Eratech S.r.l. | Procédé de préparation de suspensions concentrées et une trousse de ceci |
| TWI353855B (en) | 2005-05-26 | 2011-12-11 | Shionogi & Co | Method for preparing an aqueous solution of doripe |
| US20070249572A1 (en) * | 2005-12-20 | 2007-10-25 | Verus Pharmaceuticals, Inc. | Systems and methods for the delivery of corticosteroids |
| US20070197486A1 (en) * | 2005-12-20 | 2007-08-23 | Verus Pharmaceuticals, Inc. | Methods and systems for the delivery of corticosteroids |
| US20070160542A1 (en) * | 2005-12-20 | 2007-07-12 | Verus Pharmaceuticals, Inc. | Methods and systems for the delivery of corticosteroids having an enhanced pharmacokinetic profile |
| US20070185066A1 (en) * | 2005-12-20 | 2007-08-09 | Verus Pharmaceuticals, Inc. | Systems and methods for the delivery of corticosteroids |
| JP2009526858A (ja) * | 2006-02-15 | 2009-07-23 | ティカ レーケメデル アーベー | コルチコステロイド溶液を製造する方法 |
| GB0604141D0 (en) * | 2006-03-01 | 2006-04-12 | Arrow Int Ltd | Nebulizer formulation |
| GB0700380D0 (en) | 2007-01-09 | 2007-02-14 | Breath Ltd | Storage Of Ampoules |
| PT3222617T (pt) | 2009-03-19 | 2022-09-30 | Univ Johns Hopkins | Compostos que têm psma como alvo e as suas utilizações |
| US20180009767A9 (en) | 2009-03-19 | 2018-01-11 | The Johns Hopkins University | Psma targeted fluorescent agents for image guided surgery |
| US8273725B2 (en) * | 2009-09-10 | 2012-09-25 | Genzyme Corporation | Stable hyaluronan/steroid formulation |
| CN103616442B (zh) * | 2013-10-31 | 2015-08-19 | 中国计量学院 | 一种家畜血液中布地奈德异构体的定量检测方法 |
| WO2018232280A1 (fr) | 2017-06-15 | 2018-12-20 | The Johns Hopkins University | Agents fluorescents ciblés par psma pour chirurgie guidée par image |
| CN113133993A (zh) * | 2021-04-23 | 2021-07-20 | 海门普适医药有限公司 | 无菌吸入用混悬制剂及其制备方法 |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4695454A (en) * | 1985-04-01 | 1987-09-22 | New York Blood Center, Inc. | Process for preparing hepatitis B surface antigen containing particles in novel forms which are highly immunogenic |
| DE4240103A1 (de) * | 1992-05-26 | 1993-12-02 | Behringwerke Ag | Verfahren zur Inaktivierung von Viren in Präparationen von Proteinen |
| JPH0842982A (ja) * | 1994-05-17 | 1996-02-16 | Hde Metallwerk Gmbh | 高効率型毛管式熱交換器 |
| US5583960A (en) * | 1994-06-01 | 1996-12-10 | David Reznik | Electroheating apparatus and methods |
| US5603894A (en) * | 1994-10-31 | 1997-02-18 | Abbott Laboratories | Method of sterilizing a pharmaceutical composition |
| WO1996013279A1 (fr) * | 1994-10-31 | 1996-05-09 | Abbott Laboratories | Procede et systemes de sterilisation de medicaments sensibles a la chaleur |
| EP0722075B1 (fr) * | 1995-01-10 | 1999-09-01 | hde Metallwerk GmbH | Echangeur de chaleur à tubes capillaires de haute capacité |
| US5565947A (en) * | 1995-10-30 | 1996-10-15 | Eastman Kodak Company | Framing apparatus for a camera |
| SE9704186D0 (sv) * | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
| US6066292A (en) | 1997-12-19 | 2000-05-23 | Bayer Corporation | Sterilization process for pharmaceutical suspensions |
| ATE259220T1 (de) | 1998-05-29 | 2004-02-15 | Skyepharma Canada Inc | Gegen hitzeeinwirkung geschützte mikropartikel und verfahren zur terminalen dampfsterilisation derselben |
| EP1165148A1 (fr) * | 1999-03-30 | 2002-01-02 | Gambro Lundia AB | Procede et appareil de sterilisation d'un fluide sensible a la chaleur |
| CA2429574C (fr) * | 2000-11-24 | 2009-02-10 | Breath Limited | Sterilisation de produits pharmaceutiques |
-
2001
- 2001-11-26 CA CA002429574A patent/CA2429574C/fr not_active Expired - Fee Related
- 2001-11-26 JP JP2002544102A patent/JP4048114B2/ja not_active Expired - Fee Related
- 2001-11-26 DE DE60121023T patent/DE60121023T2/de not_active Expired - Lifetime
- 2001-11-26 GB GB0215020A patent/GB2374013C/en not_active Expired - Fee Related
- 2001-11-26 AU AU2002223896A patent/AU2002223896B9/en not_active Ceased
- 2001-11-26 DK DK01997317T patent/DK1337279T3/da active
- 2001-11-26 WO PCT/GB2001/005208 patent/WO2002041925A1/fr active IP Right Grant
- 2001-11-26 IL IL15593501A patent/IL155935A0/xx active IP Right Grant
- 2001-11-26 HU HU0302630A patent/HUP0302630A3/hu unknown
- 2001-11-26 BR BR0115584-9A patent/BR0115584A/pt not_active IP Right Cessation
- 2001-11-26 NZ NZ526118A patent/NZ526118A/en not_active IP Right Cessation
- 2001-11-26 ES ES01997317T patent/ES2266310T3/es not_active Expired - Lifetime
- 2001-11-26 CZ CZ20031446A patent/CZ301049B6/cs not_active IP Right Cessation
- 2001-11-26 EP EP01997317A patent/EP1337279B1/fr not_active Expired - Lifetime
- 2001-11-26 AT AT01997317T patent/ATE330638T1/de active
-
2002
- 2002-09-30 US US10/259,781 patent/US6863865B2/en not_active Expired - Lifetime
-
2003
- 2003-05-15 IS IS6817A patent/IS2528B/is unknown
- 2003-05-26 NO NO20032361A patent/NO327380B1/no not_active IP Right Cessation
-
2004
- 2004-01-21 HK HK04100471A patent/HK1057492A1/xx not_active IP Right Cessation
-
2006
- 2006-09-06 CY CY20061101272T patent/CY1105266T1/el unknown
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